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Tests treatment safety and results for Chronic Cholecystitis
Official title Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
ClinicalTrials.gov ID: NCT06842966
What this study is testing
What is 4-MUST?
4-MUST is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic cholecystitis.
Also referred to as trimebutine 4-methylumbelliferyl sulfate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Males and females aged 18-70 years.
- Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
- Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal...
- Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
- Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
You likely can't join if
- Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
- Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) -...
- Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
- Requirement for prohibited concomitant therapy.
- If the investigator judges that comtinued participation in the study would harm the patient.
- Pregnancy or the need for breastfeeding in the patient.
See the full eligibility criteria
- Males and females aged 18-70 years.
- Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
- Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; Diarrhea.
- Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
- Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
- Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks...
- Signed and dated informed consent from. Non-
- Peptic ulcer disease, duodenal ulcer, erosive GERD.
- Toxic megacolon.
- Paralytic ileus.
- Gilbert's syndrome.
- Abdominal adhesion disease.
- Blood in stool, unexplained weight loss, fever, anemia.
- Inflammatory and erosive gastrointestinal diseases.
- Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
- Oncological diseases of the gastrointestinal tract (including past diagnoses).
- History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.
- Use of prohibited therapy medications within 3 days prior to randomization.
- History of mental illnesses.
- Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
- Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
- Established diagnosis of liver failure, including in history and/or changes in liver enzyme activity: Increase in AST, ALT, ALP and/or γ-GTP more than 3 times above the upper limit of normal; Increase in total bilirubin...
- HIV, syphilis, viral hepatitis B or C, including in history.
- Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
- Liver cirrhosis.
- Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen their prognosis and make it impossible for the patient to participate in clinical research).
- Diabetes mellitus in a state of subcompensation and decompensation.
- Systemic connective tissue diseases.
- Autoimmune diseases.
- Need for surgical and/or endovascular treatment and/or necessity for hemodialysis procedures.
- Epilepsy or seizures of unclear etiology, including in history.
- Alcoholism, substance abuse or drug addiction, including in history.
- Uncorrected electrolyte disturbances.
- History of surgery within 6 month prior to screening.
- Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
- Patients who require prohibited concomitant therapy within this study framework.
- Participation in another clinical trial within the last 3 months prior to the screening visit date.
- Lack of willingness to cooperate from the patient's side.
- Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.
- Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
- Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain/discomfort in the upper abdomen...
- Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
- Requirement for prohibited concomitant therapy.
- If the investigator judges that comtinued participation in the study would harm the patient.
- Pregnancy or the need for breastfeeding in the patient.
- Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).
- Withdrawal of informed consent (patient's unwillingness to continue participation in the study).
- Loss of contact with the patient (inability to reach the patient via mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).
- Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.
- Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Engel's, Russia
- Ivanovo, Russia
- Moscow, Russia
- Novosibirsk, Russia
- Perm, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Tolyatti, Russia
- Veliky Novgorod, Russia
- Yaroslavl, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Engel's, Russia; Ivanovo, Russia; Moscow, Russia; Novosibirsk, Russia; Perm, Russia; Saint Petersburg, Russia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.